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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(k) Number K970422
Device Name RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS
Applicant
TRIMEDYNE, INC.
2801 BARRANCA RD.
P.O. BOX 57001
IRVINE,  CA  92619 -7001
Applicant Contact SUSAM H GAMBLE
Correspondent
TRIMEDYNE, INC.
2801 BARRANCA RD.
P.O. BOX 57001
IRVINE,  CA  92619 -7001
Correspondent Contact SUSAM H GAMBLE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/03/1997
Decision Date 04/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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